Tomorrow’s medical devices require flexible operations solutions today.
For medical device manufacturers, compliance is the first among many challenges.
The logistics involved in coordinating product development and manufacturing while meeting compliance requirements are complex. Staying on schedule requires end-to-end supply chain visibility, ensuring both the timely manufacture of devices and traceability in the event of defects. Paper-based guidance and documentation systems lead to poor visibility, siloed data, and manual work — all driving up to the cost of goods sold (COGS) and quality while delaying the release of products for shipment.
Error-prone paper-based processes
Quality and compliance are burdensome
High levels of non-value-added work
Lack of visibility due to siloed data
Tulip’s no-code platform provides a full, self-auditing eDHR solution.
Reduce the cost of quality while making compliance seamless by building Digital Logbook and Electronic Device History Record (eDHR) apps with Tulip. Ensure products are made to spec and are right the first time, every time by guiding workflows, bringing quality in-line, and enforcing compliance.
Turn your SOPs into interactive, IoT-connected apps.
Digital work instructions apps help enforce standard operating procedures (SOPs) and enforce quality in-line. Ensure staff is trained, equipment is cleaned and calibrated correctly, processes are followed, and products are made to spec. Accelerate New Product Introduction (NPI) with work instructions.
Minimize the burden of compliance-driven activities on staff.
Streamline documentation around activities, such as equipment use, line clearances, and changeovers. Ensure data integrity and traceability with electronic signatures, audit logs, and automatic data collection.
Track devices, assemblies, and components, and materials through the plant and for recalls.
Ensure 100% traceability with audit logs and a digital approval process. Automatically collect information for work order tracking, including for custom devices. Reduce the headache of recalls by quickly identifying affected devices and batches.
Enable Review by Exception for faster predictable release of products from manufacturing to customers.
Release and ship products faster by streamlining documentation and eliminate errors and the time wasted fixing them. Move faster with a self-auditing eDHR that helps you identify issues in real-time.
Gain real-time visibility into quality and production information.
Easily analyze process data for root cause analysis and optimization. Connect to ERP Databases for real-time inventory information and recording changes.
Industrial-grade compliance.
FDA GMP
EAR
GDPR
ITAR
EU GMP
Case Studies
IoT-connected apps helped Dentsply reduce errors and increase traceability.
Dentsply Sirona created apps to guide operators through their complex kitting process, allowing them to error-proof the activity while cutting training times by 75%. Dentsply furthered improved their workflow apps by leveraging pick-to-light and creating production dashboards for identifying improvement areas.